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Phase II Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Dean Felsher, Stanford University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185731
First Posted: September 16, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Leukemia and Lymphoma Society
Damon Runyon Cancer Research Foundation
Burroughs Wellcome
Information provided by (Responsible Party):
Dean Felsher, Stanford University
  Purpose

The purpose of this study is to:

  1. Determine changes in levels of tumor bioactivity upon treatment with atorvastatin.

    Secondary objective:

  2. Determine validity of tumor bioactivity as a biologic endpoint by correlation with clinical response.
  3. Determine whether administration of atorvastatin is tolerable and safe in low grade NHL patients. We do not anticipate any significant toxicity since this dose of atorvastatin has been FDA approved for patients with hypercholesterolemia.

Condition Intervention Phase
Leukemia Lymphoma, Non-Hodgkin Drug: Atorvastatin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Dean Felsher, Stanford University:

Primary Outcome Measures:
  • Determine changes in levels of tumor bioactivity upon treatment with atorvastatin. [ Time Frame: Endpoint is assessed every 3 months, up to 1 year after starting atorvastatin treatment. Fine needle aspirate and blood samples are batched and analyzed within 1 year of obtaining each sample endpoint. ]

Secondary Outcome Measures:
  • Determine validity of tumor bioactivity as a biologic endpoint by correlation with clinical response. [ Time Frame: Endpoint is assessed every 3 months, up to 1 year after starting atorvastatin treatment. ]
  • Determine whether administration of atorvastatin is tolerable and safe in low grade NHL patients. We do not anticipate any significant toxicity since this dose of atorvastatin has been FDA approved for patients with hypercholesterolemia. [ Time Frame: Endpoint is assessed every 3 months, up to 1 year after starting atorvastatin treatment. ]

Estimated Enrollment: 23
Study Start Date: April 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
Atorvastatin, 80mg tablet, will be taken orally by the patient daily, beginning on study day 1.
Drug: Atorvastatin
80 mg orally once daily
Other Name: Lipitor

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 years old
  • Disease criteria: Confirmed by Stanford Pathology to be one of the following Non-Hodgkin's Lymphoma subtypes:

    • Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL)
    • Extranodal marginal zone B-cell lymphoma
    • Nodal marginal zone B-cell lymphoma
    • Splenic marginal zone B-cell lymphoma
  • Treatment criteria

    • Untreated: watchful waiting currently appropriate (includes CLL stage 0) o OR
    • Prior treatment: watchful waiting currently appropriate o OR
    • Refractory disease
  • Staging within 4 weeks prior to enrollment (SLL, marginal zone lymphoma)

    • CT chest (date)
    • CT abdomen (date)
    • CT pelvis (date)

OR

  • Staging within 4 weeks prior to enrollment (CLL: CT not required)

    • Total White Cell Count (WBC) (Value) (date)
    • Absolute Lymphoma Cell Count (ALC) (Value) (date)
    • Measurable disease

      1. (Site)
      2. (Size) OR
    • CLL (only): Elevated Absolute Lymphoma Cell Count
  • Disease amenable to biopsy (must check at least one): Li circulating tumor cells
  • Li positive bone marrow
  • Li palpable involved site (such as lymph node) measuring >1.5 cm

ECOG performance status <2 (Karnofsky >60)

o Status score:

  • Life expectancy of greater than 3 months
  • Patients must have adequate organ and marrow function (EACH must checked "yes") (Date)

    1. Li absolute neutrophil count >1 ,000/uL
    2. Li platelets >30,000/uL
    3. Li total bilirubin within normal institutional limits
    4. Li AST(SGOT) <2.5 X institutional upper limit of normal
    5. Li ALT(SGPT) <2.5 X institutional upper limit of normal
    6. Li creatinine within normal institutional limits OR creatinine clearance >60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of child-bearing potential must have negative BetaHCG at enrollment

Exclusion Criteria:

  • Patient has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
  • Patient has not recovered from adverse events due to agents administered more than four weeks earlier
  • Patient with stable low grade lymphoma has had rituximab within 3 months Patient with relapsed or refractory disease has had rituximab within 1 month
  • Patient has not recovered from adverse events due to surgery performed 4 weeks earlier
  • Patient is receiving any other investigational agent. Known brain metastases
  • Patient has taken any statin within the past 6 months prior to enrollment in the trial
  • Patient currently abuses alcohol
  • Patient currently takes cyclosporin or gemfibrozil Patient has a prior history of rhabdomyolysis
  • Patient as uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patient is pregnant. Note: Patients are not excluded if they are breastfeeding at the time of enrollment, but breastfeeding should be discontinued if the mother is treated with atorvastatin.
  • HIV-positive patients receiving combination anti-retroviral therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185731


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Dean Felsher
The Leukemia and Lymphoma Society
Damon Runyon Cancer Research Foundation
Burroughs Wellcome
Investigators
Principal Investigator: Dean Felsher Stanford University
  More Information

Responsible Party: Dean Felsher, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00185731     History of Changes
Other Study ID Numbers: LYMNHL0020
4328-07 ( Other Identifier: Damon Runyon Cancer Research Foundation )
95140 ( Other Identifier: Stanford University Alternate IRB Approval Number )
LYMNHL0020 ( Other Identifier: Stanford University )
13683 ( Other Identifier: Stanford University IRB )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: October 12, 2017
Last Verified: March 2013

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors